Implantation system with handle and catheter and method of use thereof

ABSTRACT

A system for deploying an implantable medical device into a body lumen is disclosed. The system comprises a catheter having functional zones for stability, protection, flexibility, trackability and pushability. The system further comprises a device for deploying an implantable medical device with the catheter. A method for deploying an implantable medical device into a body lumen using the system is also disclosed.

This application is a Continuation of application Ser. No. 13/486,249,filed on Jun. 1, 2012, which is a Continuation-In-Part of U.S. patentapplication Ser. No. 12/545,982, filed on Aug. 24, 2009. The entirety ofthe aforementioned applications is incorporated herein by reference.

FIELD

The present application relates generally to medical devices and, inparticular, to a delivery system and method for introducing implantablemedical devices into a body cavity.

BACKGROUND

Implants may be placed in the human body for a variety of reasons. Forexample, stents are placed in a number of different body lumens such asblood vessels and biliary ducts; vena cava filters are implanted in thevena cava to catch thrombus sloughed off from other sites within thebody; and vaso-occlusive devices are used for the treatment ofintravascular aneurysms.

Interventional practitioners, regardless of subspecialty, have alwayshad to demonstrate profound dexterity in order to effectively andaccurately perform invasive procedures. This is particularly the casewith the delivery and deployment of implantable devices where there isvery little room for error with respect to placement. In order to assistwith placement accuracy, many interventionalists utilize scopes, such asbronchoscopes or endoscopes, ultrasound, ct scanning, or other imagingmodalities as well as various supporting instruments, guiding catheters,introducers, and other such devices during various diagnostic andinterventional procedures. However, handling the imaging modality,introduction, and access equipment, and the delivery catheter can oftenbe a clumsy process when using multiple devices especially where by thetwo devices easily disassociate from each other. Moreover, since manydelivery catheters, for one reason or another, cannot be adequatelymanaged with one hand, additional personnel are required when handlingthe scope and the delivery catheter.

Therefore, there is an existing need for a delivery system that allows aphysician to deploy an implantable device with one hand.

SUMMARY

One aspect of the present application relates to a catheter fordeploying an implantable medical device. The catheter comprises anelongated body having a distal end and a proximate end. The elongatedbody further comprises a stabilization zone at the distal end, aprotection zone located between the stabilization zone and the proximateend, a flexibility zone located between the protection zone and theproximate end, a trackability zone located between the flexibility zoneand the proximate end; a pushability zone located between thetrackability zone and the proximate end, and a connector at theproximate end for connecting to a deployment device, wherein theprotection zone is adapted to carry an implantable device and whereinthe stabilization zone and protection zone have a flexibility index ofless than 3000 mN, the flexibility zone has a flexibility index of lessthan 3500 mN, the trackability zone has a flexibility index of less than4500 mN, and the pushability zone has a flexibility index of less than6000 mN.

Another aspect of the present application relates to a method fordeploying an implantable medical device comprising: advancing thecatheter for deploying an implantable medical device, the catheterhaving a tip at its distal end and a connector at its proximate end andcomprising a stabilization zone proximate to the tip, a protection zoneproximate to the stabilization zone, a flexibility zone proximate to theprotection zone, a pushability zone proximate to the trackability zoneand a strain relief area between the flexibility zone and the connectorinto a body lumen, wherein an implantable medical device affixed to theprotection zone of said catheter, attaching the proximal end of thecatheter to an advancing device, the advancing device comprising: a basemember comprising a base handle; and a deployment extension having adistal end and a proximate end, the proximate end is connected to thebase handle; a first tubular member that fits over the deploymentextension and is longitudinally slidable over the deployment extension,the first tubular member comprising: a first tubular body with a distalend and a proximal end; and a first handle for controlling movement ofthe first tubular member; and a second tubular member that fits over thefirst tubular member and is longitudinally slidable over the firsttubular member, the second tubular member comprising: a second tubularbody with a distal end and a proximal end; and a second handle forcontrolling movement of the second tubular member, wherein the firsthandle is located between the base handle and the second handle andwherein the distal ends of the deployment extension, the first tubularbody, and the second tubular body are adapted to deploy an implantablemedical device, and retracting the first tubular member and the secondtubular member towards the base member to deploy the implantable medicaldevice in the body lumen.

Another aspect of the present application relates to a kit comprising: acatheter for deploying an implantable medical device, the catheterhaving a tip at its distal end and a connector at its proximate end andcomprising a stabilization zone proximate to the tip, a protection zoneproximate to the stabilization zone, a flexibility zone proximate to theprotection zone, a pushability zone proximate to the flexibility zoneand a strain relief area between the pushability zone and the connector,and an advancing device, the advancing device comprising: a base membercomprising a base handle; and a deployment extension having a distal endand a proximate end, the proximate end is connected to the base handle;a first tubular member that fits over the deployment extension and islongitudinally slidable over the deployment extension, the first tubularmember comprising: a first tubular body with a distal end and a proximalend; and a first handle for controlling movement of the first tubularmember; and a second tubular member that fits over the first tubularmember and is longitudinally slidable over the first tubular member, thesecond tubular member comprising: a second tubular body with a distalend and a proximal end; and a second handle for controlling movement ofthe second tubular member, wherein the first handle is located betweenthe base handle and the second handle and wherein the distal ends of thedeployment extension, the first tubular body, and the second tubularbody are adapted to deploy an implantable medical device.

Further objectives, features and advantages of the invention will beapparent from the following detailed description taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

For the purposes of this disclosure, unless otherwise indicated,identical reference numerals used in different figures refer to the samecomponent.

FIG. 1A shows a perspective view of an exemplary a catheter device 40 ofthe present application. FIG. 1B shows the catheter device 40 attachedto a delivery device 100 in a pre-deployment configuration.

FIGS. 2A-C show a view of the catheter device 40 comprising radio opaquemarkers in the protection zone 43.

FIG. 3 shows a perspective view of an exemplary delivery device 100 in apre-deployment configuration.

FIGS. 4A-4C are perspective views of an embodiment of the base member ofthe delivery system 100.

FIGS. 5A-5C are perspective views of the first tubular member of thedelivery system 100.

FIGS. 6A-6C are perspective view of the first tubular member in aretracted position.

FIGS. 7A-7C are perspective views of the second tubular member of thedelivery system 100.

FIGS. 8A-8C are perspective views of the exemplary delivery system 100in a deployment configuration.

FIG. 9 shows a perspective view of another exemplary delivery system 100in a pre-deployment configuration.

FIG. 10 is a diagram comparing trackability force of the catheter of thepresent application (EX) to that of other comparable devices (C1-C8).

FIG. 11 is a diagram comparing ease of flexibility of the catheter ofthe present application (EX) to that of other comparable devices(C1-C6).

FIG. 12 is a diagram comparing deployment accuracy of the catheter ofthe present application (EX) to that of comparable devices (C1-C6).

DETAILED DESCRIPTION

The following detailed description is presented to enable any personskilled in the art to make and use the invention. For purposes ofexplanation specific nomenclature is set forth to provide a thoroughunderstanding of the present invention. However, it will be apparent toone skilled in the art that these specific details are not required topractice the invention. Descriptions of specific applications areprovided only as representative examples. The present invention is notintended to be limited to the embodiments shown, but is to be accordedthe widest possible scope consistent with the principles and featuresdisclosed herein.

One aspect of the present application relates to a catheter fordeploying an implantable medical device. The catheter has an elongatedbody with a distal end and a proximate end. The elongated body comprisesa stabilization zone at the distal end, a protection zone adapted tocarry a medical device and located between the stabilization zone andthe proximate end and is proximate to the stabilization, a flexibilityzone located between the protection zone and the proximate end and isproximate to the protection zone, a trackability zone located betweenthe flexibility zone and the proximate end and is proximate to theflexibility zone, a pushability zone located between the trackabilityzone and the proximate end and is proximate to the trackability zone,and a connector at the proximate end to connect the catheter to adelivery device.

Among the multiple zones of the elongated body, the stabilization andprotection zones have the highest flexibility to facilitate placement ofthe medical device, such as a stent, carrying on the protection zone.The flexibility zone has a flexibility that equals to, or is less than,that of the stabilization and protection zones. The trackability zonehas a flexibility that is less than that of the pushability zone. Thepushability zone is the least flexible zone and has enough rigidity tofacilitate advancement of the distal portion of the catheter body. Asused herein, flexibility for each zone is determined by a 3-pointbending deflection test performed according to ASTM Standards 790. Thetest results, expressed in the units of milli-Newton (mN), is referredto as the “flexibility index” of the tested material. In general, thehigher is the flexibility index, the lower is the flexibility of thetested material.

In some embodiments, the different zones have different materialcompositions in order to achieve desired flexibility. In some otherembodiments, zones of different flexibility are connected throughtransition areas. Each transition area is an area of intermediateflexibility between the adjacent zones it resides between. In someembodiments, the transition area consist of a gradual mixture of thepolymer mixture of one zone into the adjacent zone, or a gradual changein the weave pattern of the polymer from one zone into the adjacentzone.

In some embodiment, the distal end of the stability zone contains a tipthat allows the catheter to move through a body lumen without damagingthe tissue lining of the body lumen due to the conical elongated tipmade of a polyemite blend that allows for a soft flexible contour whentraversing various tortuous lumens.

In some embodiments, the elongated body further contains a strain reliefarea between the pushability zone and the connector that reduces thepressure of the pushability zone closest to the handle to allow for thearea to flex while applying significant pushing pressure thuseliminating the potential for kinking. The strain relief is made ofalternating undulating open and closed levels that allow for compressionand bending much like that of a standard computer cord or iron. It ismore flexible than the pushability zone.

In one embodiment, the catheter further comprises an implantable medicaldevice affixed to the protection zone. In a related embodiment, theimplantable medical device is a stent.

In another embodiment, the protection zone comprises an inflatableballoon for deploying the implantable medical device.

In another embodiment, the stabilization zone is coated with orcomprises an embedded radio-opaque substance.

In another embodiment, the protection zone is coated with or comprisesan embedded radio-opaque substance.

In another embodiment, the flexibility zone is coated with or comprisesan embedded radio-opaque substance.

In another embodiment, the trackability zone is coated with or comprisesan embedded radio-opaque substance.

In another embodiment, the pushability zone is coated with or comprisesan embedded radio-opaque substance.

Another aspect of the present application relates to a method fordeploying an implantable medical device comprising: advancing the acatheter for deploying an implantable medical device, the catheterhaving a tip at its distal end and a connector at its proximate end andcomprising a stabilization zone proximate to the tip, a protection zoneproximate to the stabilization zone, a flexibility zone proximate to theprotection zone, a pushability zone proximate to the flexibility zoneand a strain relief area between the pushability zone and the connectorinto a body lumen, wherein an implantable medical device affixed to theprotection zone of said catheter, attaching the proximal end of thecatheter to an advancing device, the advancing device comprising: a basemember comprising a base handle; and a deployment extension having adistal end and a proximate end, the proximate end is connected to thebase handle; a first tubular member that fits over the deploymentextension and is longitudinally slidable over the deployment extension,the first tubular member comprising: a first tubular body with a distalend and a proximal end; and a first handle for controlling movement ofthe first tubular member; and a second tubular member that fits over thefirst tubular member and is longitudinally slidable over the firsttubular member, the second tubular member comprising: a second tubularbody with a distal end and a proximal end; and a second handle forcontrolling movement of the second tubular member, wherein the firsthandle is located between the base handle and the second handle andwherein the distal ends of the deployment extension, the first tubularbody, and the second tubular body are adapted to deploy an implantablemedical device, and retracting the first tubular member and the secondtubular member towards the base member to deploy the implantable medicaldevice in the body lumen.

In one embodiment, the implantable medical device is a stent.

In another embodiment, the method further comprises attaching a viewingdevice to the base member. In a related embodiment the viewing device isan endoscope. In another related embodiment, the viewing device is afiber optic based viewing device.

In another embodiment, the body lumen is a blood vessel or a bile duct.

Another aspect of the present application relates to a kit comprising: acatheter for deploying an implantable medical device, the catheterhaving a tip at its distal end and a connector at its proximate end andcomprising a stabilization zone proximate to the tip, a protection zoneproximate to the stabilization zone, a flexibility zone proximate to theprotection zone, a pushability zone proximate to the flexibility zoneand a strain relief area between the pushability zone and the connector,and an advancing device, the advancing device comprising: a base membercomprising a base handle; and a deployment extension having a distal endand a proximate end, the proximate end is connected to the base handle;a first tubular member that fits over the deployment extension and islongitudinally slidable over the deployment extension, the first tubularmember comprising: a first tubular body with a distal end and a proximalend; and a first handle for controlling movement of the first tubularmember; and a second tubular member that fits over the first tubularmember and is longitudinally slidable over the first tubular member, thesecond tubular member comprising: a second tubular body with a distalend and a proximal end; and a second handle for controlling movement ofthe second tubular member, wherein the first handle is located betweenthe base handle and the second handle and wherein the distal ends of thedeployment extension, the first tubular body, and the second tubularbody are adapted to deploy an implantable medical device.

In one embodiment, the kit further comprises an implantable medicaldevice. In a related embodiment, the implantable medical device is astent.

In another embodiment, the kit further comprises a guidewire.

In another embodiment, the kit further comprises an introducer sheath.

In another embodiment, the kit further comprises a viewing deviceattachable to the base member. In a related embodiment, the viewingdevice is an endoscope.

FIG. 1A shows an embodiment of the catheter device 40 of the presentapplication. The catheter device 40 comprises a tip 41 at the end of thecatheter device 40 most distal to the delivery system 100. Immediatelyproximate to the tip 41 are functional zones of the catheter device 40for stabilization 42, protection 43, flexibility 44, trackability 45,and pushability 46. Immediately proximate to the pushability zone 46 isa region of the catheter device 40 serving as a strain relief area 47and a connector 48 for attaching the catheter device 40 to a deliverydevice 100 described herein or to some other type of medical device.FIG. 1B is a diagram showing the catheter device 40 attached to thedelivery device 100.

In particular embodiments, the diameters of the zones of the cathetermay be the same as one another or different. In particular embodiments,the durometer, or hardness, of the different zones may be the same asone another or different. In particular embodiments, the different zonesmay be made of the same material, or from different materials. Inparticular embodiments, a zone of the catheter may comprise a materialselected from a nylon, PEBAX (polyether block amide; Arkema, Columbes,France), a polyether block amide that is free of plasticizers, apolyamide, polyetheretherketone (PEEK), any other suitable polymermaterial, and combinations thereof.

In a particular embodiment the distal end of the catheter device 40comprises a tip 41 that allows the catheter to move into or through abody lumen without catching on or damaging the tissues lining said bodylumen. In a further particular embodiment, the tip 41 comprises aradio-opaque substance that is visible under fluoroscopy. In a stillfurther embodiment, the radio-opaque substance is embedded into orsealed within the tip 41. In another still further embodiment, the tip41 is coated or painted with the radio-opaque substance.

In another particular embodiment, the catheter device 40 comprises a“stability” zone 42 immediately proximate to the distal tip 41. Thestabilization zone 42 provides an area of the catheter distal to theregion upon which the implantable medical device is carried thatenhances the stability of the catheter during deployment of theimplantable medical device in the body lumen.

In a related embodiment, the length of said stabilization zone 42 isbetween about 1 mm and about 7 mm. In a further embodiment, the lengthof said stabilization zone 42 is between about 1 mm and about 5 mm. In astill further embodiment, the length of said stabilization zone 42 isbetween about 2 mm and about 4 mm. In a yet still further embodiment,the length of said stabilization zone 42 is about 3 mm. In a particularembodiment, the stabilization zone 42 has a flexibility index of about2000-4000 mN in a 3 point bending deflection test. In anotherembodiment, the stabilization zone 42 has a flexibility index of aboutless than 3000 mN in a 3-point bending deflection test. In a furtherembodiment, the stabilization zone 42 has a flexibility index of about2700-3000 mN in a 3 point bending deflection test. All 3-point bendingdeflection tests described hereinafter are performed using the ASTMStandards 790

In a further particular embodiment, the stabilization zone 42 comprisesa magnetic or ferrous material that allows the direction of the catheterto be manipulated during insertion with an externally controlledmagnetic field.

In another related embodiment, the magnitude of the externallycontrolled magnetic field is between about 0.01 Tesla and about 0.5Tesla. In a further embodiment, the magnitude of the externallycontrolled magnetic field is between about 0.05 Tesla and about 0.2Tesla. In a still further embodiment, the magnitude of the externallycontrolled magnetic field is between about 0.08 Tesla and about 0.1Tesla.

In another particular embodiment, the catheter device 40 comprises a“protection” zone 43 immediately proximate to the stabilization zone 42.The protection zone 43 comprises an area upon which an implantablemedical device is emplaced for insertion and implantation in a bodylumen. In a particular embodiment, the implantable medical device is astent.

In particular embodiments, the area upon which the implantable medicaldevice is emplaced comprises an inflatable balloon. Inflation of theballoon upon which the implantable medical device is emplaced causes theimplantable medical device to expand against the walls of the bodylumen. Subsequent deflation of said area leaves the implantable medicaldevice expanded against the walls of the body lumen and dissociates theimplantable medical device from the catheter in general and from theprotection zone 43 in particular.

In some embodiments, as shown in FIGS. 2A-C, the protection zone furthercomprises at least one radio-opaque marker coated onto the catheter. Inparticular embodiments, the at least one radio-opaque marker is acoating of tungsten in urethane. In some embodiments, the marker issealed by overcoating with an additional layer of urethane. In someembodiments, the at least one radio-opaque marker is an integratedtantal marker (ITM). Coating of at least one radio-opaque marker ontothe protection zone 43 of the catheter 40 allows for the elimination ofmarker bands on the device, giving the device a lower profile andallowing more flexibility and pushability of the catheter device 40because there are no defects in the device for the seating of markers.Additionally, the at least one radio-opaque marker in the protectionzone 43 of the catheter 40 allows for the visualization of the exactplacement of the stent or other implantable medical device.

FIG. 2A is an exemplary depiction of a single tungsten-containingradio-opaque marker 51 spanning the length of the protection zone 43. Insome embodiments, the single tungsten-containing radio-opaque marker 51does not span the entire length of the protection zone 43, but is thesame length as the implantable medical device.

FIG. 2B is an exemplary depiction of a pair of tungsten-containingradio-opaque markers 52 at the ends of the protection zone 43. In someembodiments, the pair of tungsten-containing radio-opaque markers 52 aredirectly under the proximal and distal ends of the implantable medicaldevice. In other embodiments, the pair of tungsten-containingradio-opaque markers 52 are immediately proximal and distal to the endsof the implantable medical device.

FIG. 2C is an exemplary depiction of a pair of integrated tantal markers53 at the ends of the protection zone 43. In some embodiments, the pairof integrated tantal markers 53 are directly under the proximal anddistal ends of the implantable medical device. In other embodiments, thepair of integrated tantal markers 53 are immediately proximal and distalto the ends of the implantable medical device.

In another related embodiment, the length of the protection zone 43 isbetween about 50 mm and about 250 mm. In a further embodiment, thelength of the protection zone 43 is between about 100 mm and about 200mm. In a still further embodiment, the length of the protection zone 43is about 152 mm. In a particular embodiment, the protection zone 43 hasa flexibility index of about 2000-4000 mN in a 3 point bendingdeflection test. In another embodiment, the protection zone 43 has aflexibility index of about less than 3000 mN in a 3-point bendingdeflection test. In a further embodiment, the protection zone 43 has aflexibility index of about 2700-3000 mN in a 3 point bending deflectiontest.

In a particular embodiment, the catheter device 40 further comprises aprotective sheath that extends from the delivery device 100 to andcovering the implantable medical device emplaced on the protection zone43. When the catheter has been inserted to the point where theimplantable medical device is to be deployed, the first handle 24 offirst tubular member is withdrawn towards base handle 12, withdrawingthe protective sheath towards the delivery system and exposing theimplantable medical device.

In some embodiments, the implantable medical device is a self-expandingstent or other implantable device, wherein drawing back of the sheathallows the device to immediately expand against the walls of the bodylumen.

In another particular embodiment, the catheter device 40 comprises a“flexibility” zone 44 immediately proximate to the protection zone 43.The flexibility zone 44 of the catheter is flaccid enough to allow thedirection of the tip 41, stabilization zone 42 and protection zone 43 tobe easily guided by the externally controlled magnetic field, however isrigid enough to prevent the zone from collapsing or folding as thecatheter is being advanced into/through the body lumen.

In a related embodiment, the flexibility zone 44 is between about 50 mmand about 150 mm. In a further embodiment, the length of the flexibilityzone 44 is between about 70 mm and about 120 mm. In a still furtherembodiment, the length of the flexibility zone 44 is about 90 mm. In aparticular embodiment, the flexibility zone 44 has a flexibility indexof about 2000-4000 mN in a 3 point bending deflection test. In anotherembodiment, the flexibility zone 44 has a flexibility index of aboutless than 3500 mN in a 3-point bending deflection test. In a furtherembodiment, the flexibility zone 44 has a flexibility index of about3000 mN in a 3 point bending deflection test. In particular embodiments,the flexibility index of the flexibility zone 44 is higher than that ofthe of the flexibility index of the stabilization zone 42 or theprotection zone 43. In some embodiments, the flexibility index of theflexibility zone 44 is within the range of about 100%-110% of theflexibility index of the stabilization zone 42 or the protection zone43.

In another particular embodiment, the catheter device 40 comprises a“trackability” zone 45 immediately proximate to the flexibility zone 44.The trackability zone 45 is of an intermediate flexibility between thatof the more flexible flexibility zone 44 and the more rigid pushabilityzone 46. In a particular embodiment, the trackability zone 45 has aflexibility index of about 3000-5000 mN in a 3 point bending deflectiontest. In another embodiment, the trackability zone 45 has a flexibilityindex of about less than 4500 mN in a 3-point bending deflection test.In a further embodiment, the trackability zone 45 has a flexibilityindex of about 3900-4100 mN, more particularly of about 4000 mN, in a 3point bending deflection test. In particular embodiments, theflexibility index of the trackability zone 45 is higher than that of theof the flexibility index of the flexibility zone 44. In someembodiments, the flexibility index of the trackability zone 45 is withinthe range of about 110%-150% of the flexibility index of the flexibilityzone 44. The intermediate rigidity of the trackability zone allows thecatheter device 40 to easily track through complex bends in a lumen orvessel without kinking or folding. In some embodiments, a radio-opaquesubstance is embedded into the trackability zone 45. In another stillfurther embodiment, the trackability zone 45 is coated or painted with aradio-opaque substance.

In a related embodiment, the trackability zone 45 is between about 100mm and about 300 mm. In a further embodiment, the length of thetrackability zone 45 is between about 150 mm and about 250 mm. In astill further embodiment, the length of the trackability zone 45 isabout 195 mm.

In certain embodiments, the catheter device 40 comprises a “pushability”zone 46. In one embodiment, the pushability zone 46 is immediatelyproximate to the trackability zone 45. The pushability zone 46 is arelatively rigid zone of the catheter that allows the practitioner toapply force in order to advance the catheter device 40 into/through thebody lumen or vessel. The pushability zone 46 may be made of anybiocompatible material with suitable hardness and rigidity for thedelivery of the implantable medical device, but is flexible enough toallow the catheter to bend and twist through body lumensor vessels. Inparticular embodiments the biocompatible material is made of nylon, apolyamide, or polyetheretherketone (PEEK). In some embodiments, thepushability zone is more rigid than the trackability zone 45. In otherembodiments, the pushability zone and the trackability zone have aboutthe same rigidity. In a particular embodiment, the pushability zone 46has a flexibility index of about 4000-7000 mN in a 3 point bendingdeflection test. In another embodiment, the pushability zone 46 has aflexibility index of about less than 6000 mN in a 3-point bendingdeflection test. In a further embodiment, the pushability zone 46 has aflexibility index of about 5200-5700 mN in a 3 point bending deflectiontest, more particularly about 5300 mN. In particular embodiments, theflexibility index of the trackability zone 45 is within about 25% of theflexibility index of the trackability zone 45.

In a related embodiment, the pushability zone 46 is between about 100 mmand about 620 mm. In a further embodiment, the length of the pushabilityzone 46 is between about 230 mm and about 490 mm. In a still furtherembodiment, the length of the pushability zone 46 is about 360 mm.

In a separate related embodiment, the pushability zone 46 is betweenabout 500 mm and about 1020 mm. In a further embodiment, the length ofthe pushability zone 46 is between about 630 mm and about 890 mm. In astill further embodiment, the length of the pushability zone 46 is about760 mm. In another still further embodiment, the length of thepushability zone 46 is about 767 mm.

In a particular embodiment, the total combined length of thestabilization zone 42, protection zone 43, flexibility zone 44,trackability zone 45 and pushability zone 46 is about 800 mm. In anotherparticular embodiment, the total combined length of the stabilizationzone 42, protection zone 43, flexibility zone 44, trackability zone 45and pushability zone 46 is about 1200 mm. In still another particularembodiment, the total combined length of the stabilization zone 42,protection zone 43, flexibility zone 44, trackability zone 45 andpushability zone 46 is about 1207 mm.

In particular embodiments, the catheter device 40 further comprisestransition areas between the stabilization zone 42 and the protectionzone 43, between the protection zone 43 and the flexibility zone 44,between the flexibility zone 44 and the trackability zone 45, and/orbetween the trackability zone 45 and the pushability zone 46. Eachtransition area is an area of intermediate flexibility between theadjacent zones it resides between, consisting of a gradual mixture ofthe polymer mixture of one zone into the adjacent zone, or a gradualchange in the weave pattern of the polymer from one zone into theadjacent zone.

In another particular embodiment, a radio-opaque substance is coated onor embedded into the stabilization zone 42.

In another particular embodiment, a radio-opaque substance is coated onor embedded into the protection zone 43.

In another particular embodiment, a radio-opaque substance is coated onor embedded into the flexibility zone 44.

In another particular embodiment, a radio-opaque substance is coated onor embedded into the pushability zone 46.

In another particular embodiment, a radio-opaque substance is coated onor embedded into the entire catheter 40.

In a particular embodiment, the catheter device 40 further comprises a“strain relief” area 47 that is proximate to the pushability zone 46 anddistal to an instrument for deploying an implantable medical device in abody lumen, such as the delivery device 100 as described herein. Saidstrain relief area 47 is interposed between the catheter device 40 and aconnector unit 48 attached to the instrument for deploying animplantable medical device in a body lumen.

In a particular embodiment, the connector unit 48 comprises aY-connector that allows the attachment of a fluid reservoir or syringe.Said fluid reservoir or syringe may comprise an opacity enhancingsubstance that allows visualization of the balloon when it is inflated.In another particular embodiment, said fluid reservoir is emplacedbetween the connector unit 48 and the delivery device 100. In a furtherembodiment, the connector unit 48 is attached to the delivery device 100at distal end 32 of the second tubular member 30.

FIGS. 3-9 show more details of the delivery device 100. The deliverydevice 100 allows the user to install the implantable device with onehand. As shown in FIG. 3, an embodiment of the delivery device 100contains a base member 10, a first tubular member 20 that fits over thedeployment extension 12 and is longitudinally slidable along thedeployment extension 12, and a second tubular member 30 that fits overthe first tubular member 20 and is longitudinally slidable along thefirst tubular member 20. As shown in FIGS. 4A-4C, the base member 10contains a base handle 11 and a deployment extension 12. The deploymentextension 12 is a rod-like structure having a proximate end 13, a distalend 14, and a pair of compression stopper 16 (one on each side of theextension 12, see e.g., FIG. 4C) near the proximate end 13 to preventthe device from being over deployed. The proximate end 13 of thedeployment extension 12 is removably or permanently connected to thebase handle 11. In this embodiment, the base handle 11 further containsa guiding extension 15 that matches with a stabilizing ring on the firsttubular member 20 to prevent rotation of the first tubular member 20.

In another embodiment, the base member 10 further contains a scopecoupling device so that an optical device, such as an endoscope or abroncoscope, may be attached to the deployment extension 12 tofacilitate the deployment of the implantable medical device. In certainembodiments, the scope coupling mechanism allows for the manipulation ofthe scope (e.g., rotate) with respect to the base member 10 when thescope is coupled to the based member 10. In other embodiments, the basemember 10 further contains a guide wire coupling device so that a guidewire may be attached to the deployment extension 12 to facilitate thedeployment of the implantable medical device.

As shown in FIGS. 5A-5C, the first tubular member 20 contains a firsttubular body 21 with a distal end 22 and a proximal end 23, and a firsthandle 24 for controlling movement of the first tubular member 20. Thefirst tubular body 21 has a center lumen with a cross-sectional shapeadopted to fit the outside contour of the deployment extension 12 and toslide longitudinally along the deployment extension 12. The first handle24 further contains a stabilizing ring 25 that fits over the guidingextension 15 of the base handle 12. As shown in FIG. 3, the stabilizingring 25 slides along the guiding extension 15 of the base handle 11 andprevents rotation of the first tubular member 20 along the central axisof the deployment extension 12. The first tubular member 20 isdissociable from the base member 10 by sliding off from the distal end14 of the deployment extension 12. FIGS. 6A-6C show the first tubularmember 20 in a retracted position with the base member 10.

As shown in FIGS. 7A-7C, the second tubular member 30 contains a secondtubular body 31 having a distal end 32 and a proximal end 33, and asecond handle 34 for controlling movement of the second tubular member30. The second tubular body 31 has a center lumen with a cross-sectionalshape adopted to fit the outside contour of the first tubular body 21and to slide longitudinally along the first tubular body 21. The secondtubular member 30 is dissociable from the first tubular member 20.

As shown in FIGS. 3 and 8A-8C, the first tubular member 20 is connectedto the base member 10 through an under-to-over connection. In otherwords, the first tubular member 20 is connected to the base member 10 bysliding the first tubular body 21 over the deployment extension 12 andthe stabilizing ring 25 over the guiding extension 15. Similarly, thesecond tubular member 30 is also connected to the first tubular member20 through an under-to-over connection, i.e., by sliding the secondtubular body 31 over the first tubular body 21. A person of ordinaryskill in the art would understand that the connection can be done in anumber of sequences depending on the length of the implantable medicaldevice to be delivered.

In one embodiment, the device 100 also includes an interlocking featurethat allows the first tubular member 20 to be locked relative to thesecond tubular member 30. In one embodiment, the interlocking featureincludes a locking tab 26 on the first tubular member 20 and a matchinglocking hole 33 on the second tubular member 30. As shown in FIG. 3, thelocking tab 26 engages with the locking hole 36 to prevent the secondtubular member 30 from falling off from the distal end of the firsttubular member 20. The tab 26, however, has a beveled front side thatallows the second tubular member 30 to slide over the locking tab 26towards the proximate end 23 of the first tubular body. In anotherembodiment, the first tubular member 20 further contains a locking guide27 (see FIGS. 5A-5C). In other embodiments, the device 100 furtherincludes a second interlocking feature that allow the first tubularmember 20 to be locked relative to the base member 10.

The distal ends of the deployment extension 12, the first tubular body21 and the second tubular body 31 are configured to hold, contain orattach to an implantable device. As used herein, the term “implantabledevice” is broadly interpreted to include stents and other medicaldevices that can be placed into a body lumen or body cavity. Theimplantable devices include implantable devices of the Stent TechnologySystem (STS) family developed by ALVEOLUS®, as well as implantabledevices developed in accordance with U.S. patent application Ser. Nos.10/190,770, 10/288,615, and 60/493,402 and International PatentApplication Ser. No. PCT/DE02/01244, which are incorporated in theirentirety by this reference.

The distal portion of the device can be configured to accommodatevariable shafts to allow for ease of manufacturing andinterchangeability of varying catheter diameters. In one embodiment, thedistal end 14 of the deployment extension 12, the distal end 22 of thefirst tubular body 21, or the distal end 32 of the second tubular body31 is configured such that a catheter may be removably attached to thedistal end 14, 22 or 32. For example, the catheter may be screwed ontothe distal end 14, 22 or 32, or coupled to the device by otherconventional means such as a luer, hub, or other standard attachmentmechanism.

As would be understand by one skilled in the art, the device 100 is aproportional release system. In certain embodiment, only the base member10 and the first tubular member 20 are assembled together for deploymentof implantable medical devices within a certain length range (e.g., lessthan about 50 mm). In other embodiment, the base member 10, the firsttubular member 20, and the second tubular member 30 are assembledtogether for deployment of implantable medical devices having a greaterlength (e.g., about 50 mm to 100 mm). The multi-handle design allows forsingle-handed placement of the device 100. The parallel guide sheathoffered by the deployment extension 12 and the guiding extension 15provides stability and eliminates rotation of the first tubular memberrelative to the base member 10. The unique guide sheath also allowsindex finger rest during deployment. Finger guide for index finger restfor ease of stability and precision placement. In one embodiment, thefirst tubular member 20 and/or the second tubular member 30 arecontoured on one side or on both sides for easy handling with the indexfinger.

The handles 11, 24 and 34 can be pulled together with a single hand. Inone embodiment, the handles can be interlocked into each other in amale- and female connection. For example, the second handle 34 may havea hollow interior to accommodate the first handle 24. Similarly, thefirst handle 24 may have a hollow interior to accommodate the basehandle 11. In one embodiment, both the second handle 34 and the firsthandle 24 may wrap around base handle 11 when fully compressed. Inanother embodiment, the second handle 34 is spaced at specific distancesfrom the first handle 24 and the base handle 11 to optimize the closercomfort for the device and improve placement accuracy. The handles mayhave a beveled or rounded shape to improve ergonomics.

The device 100 may be made of any biocompatible material with suitablehardness and rigidity for the delivery of the implantable medicaldevice. The device should have sufficient flexibility to adapt toanatomical curvatures without loss of ability to push or pull. In oneembodiment, the device is made from a plastic material that can bemolded to reduce production cost. In other embodiment, the individualparts of the device 100, such as the base member 10, the first tubularmember 20 and the second tubular member 30 are interchangeable amongdifferent devices 100. The interchangeable parts allow the device 100 tobe manufactured in different configurations, such as in a single handle(base member only), double handle (base member+first tubular member),triple handle (base member+first tubular member+second tubular member)or more complex configurations.

The diameter and the length of the deployment extension 12, the firsttubular body 21 and/or the second tubular body 31, may be designed incompliant with the implantable devices to be delivered and the insertionprocedure to be employed. The dimensions of the device must offer enoughspace for crimped implantable devices. Each individual part of thedevice should have smooth outer and inner surfaces to provide lowfriction between the moving parts. In certain embodiments, thedeployment extension 12, as well as the first tubular body 21, hasexternal measurement markers 18 and 28 for the determination ofretraction distance (FIG. 9).

Also disclosed is a method for delivering an implantable medical deviceusing the delivery device of the present application. The methodincludes the steps of: attaching the first tubular member 20 to the basemember 10 by sliding the first tubular body 21 over the implantablemedical device and the deployment extension 12; attaching the secondtubular member 30 to the base member 10 by sliding the second tubularbody 31 over the first tubular body 21; attaching a proximate end of acatheter to the distal end 32 of the second tubular body 31, wherein animplantable medical device is attached to a distal end of the catheter;advancing the distal end of the catheter into a body lumen; retractingthe first tubular member 20 and the second tubular member 30 towards thebase member 10 to deploy the medical device. The order of retraction canvary. In one embodiment, the first tubular member 20 is retracted first,followed with the retraction of the second tubular member 30. In anotherembodiment, the second tubular member 30 is retraced first, followedwith the retraction of the first tubular member 20.

The retraction of the first or second tubular member can be easilyperformed with a single hand using handles 24 or 34. In one embodiment,a user of the device 100 can hold the base handle 11, pull the firsthandle 24 towards the base handle 11 and hence retract the first tubularmember 20. Alternatively, the user may first hold the first handle 24,pull the second handle 34 towards the first handle 24 and hence retractthe second tubular member 30. As the second tubular body 31 is retractedover the first tubular body 21, the implantable device is exposed anddeployed.

The present invention is further illustrated by the following examplewhich should not be construed as limiting. The contents of allreferences, patents and published patent applications cited throughoutthis application, as well as the Figures and Tables, are incorporatedherein by reference.

Example 1 Deployment of an Implantable Medical Device

An introducer sheath is inserted in an appropriate site in order to gainaccess to a vessel or lumen.

A guide wire is inserted through the introducer sheath and advancedthrough the vessel or lumen to span the area where the implantablemedical device is to be deployed.

The tip 41 of the catheter device 40 is advanced onto the guide wire andthe catheter device 40 is advanced through the introducer sheath intothe vessel or lumen. The catheter device 40 is advanced through thevessel or lumen such that the stabilization zone 42 is advanced beyondthe deployment site and the implantable medical device on the protectionzone 43 is directly within the deployment site.

The protective sheath is withdrawn by pulling handle 24 toward basehandle 11, thereby exposing the implantable medical device at thedeployment site.

The implantable medical device is deployed at the site by pulling handle34 towards handle 24 and base handle 11, thereby inflating theprotection zone 43 and expanding the implantable medical device againstthe walls of the lumen.

Following deployment of the implantable medical device, the catheterdevice 40 is withdrawn from the vessel or lumen. The guide wire andintroducer sheath are removed and the incision at the entry point issutured.

Example 2 Benefits of the Catheter of the Present Application

The catheter of the present application were tested against a number ofcomparable catheter products. As shown in FIGS. 10-12, the catheter ofthe present application exhibits the best trackability, flexibility anddeployment accuracy among the catheters tested.

The above description is for the purpose of teaching the person ofordinary skill in the art how to practice the present invention, and itis not intended to detail all those obvious modifications and variationsof it which will become apparent to the skilled worker upon reading thedescription. It is intended, however, that all such obviousmodifications and variations be included within the scope of the presentinvention, which is defined by the following claims. The claims areintended to cover the claimed components and steps in any sequence whichis effective to meet the objectives there intended, unless the contextspecifically indicates the contrary.

What is claimed is:
 1. A method for deploying an implantable medicaldevice comprising; advancing a catheter into a body lumen, the cathetercomprises: an elongated body having a distal end and a proximate end,the elongated body further comprising: a stabilization zone at thedistal end; a protection zone located between the stabilization zone andthe proximate end, wherein the protection zone is adapted to carry animplantable device; a flexibility zone located between the protectionzone and the proximate end; a trackability zone located between theflexibility zone and the proximate end; a pushability zone locatedbetween the trackability zone and the proximate end; a connector at theproximate end for connecting to an advancing device; and the implantablemedical device affixed to the protection zone; attaching the proximalend of the catheter to the advancing device, the advancing devicecomprising: a base member comprising a base handle; and a deploymentextension having a distal end and a proximate end, the proximate end isconnected to the base handle, wherein the distal end of the deploymentextension is configured to accommodate variable shafts to allow forinterchangeability of varying catheter diameters; a first tubular memberthat fits over the deployment extension and is longitudinally slidableover the deployment extension, the first tubular member comprising: afirst tubular body with a distal end and a proximal end; and a firsthandle for controlling movement of the first tubular member, the firsthandle disposed between the first tubular body and the guidingextension; and a second tubular member that fits over the first tubularmember and is longitudinally slidable over the first tubular member, thesecond tubular member comprising: a second tubular body with a distalend and a proximal end; and a second handle for controlling movement ofthe second tubular member, wherein the first handle is located betweenthe base handle and the second handle and wherein the distal ends of thedeployment extension, the first tubular body, and the second tubularbody are adapted to deploy an implantable medical device, and retractingthe first tubular member and the second tubular member towards the basemember to deploy the implantable medical device in the body lumen. 2.The method of claim 1, wherein the implantable medical device is astent.
 3. The method of claim 1, further comprising attaching a viewingdevice to the base member.
 4. The method of claim 3, wherein the viewingdevice is an endoscope.
 5. The method of claim 1, wherein the body lumenis a blood vessel or a bile duct.
 6. The method of claim 1, wherein theprotection zone of the catheter comprises an inflatable balloon fordeploying the implantable medical device.
 7. The method of claim 1,wherein the tractability zone of the catheter is coated with orcomprises an embedded radio-opaque substance.
 8. The method of claim 1,wherein the stabilization zone of the catheter is coated with orcomprises an embedded radio-opaque substance.
 9. The method of claim 1,wherein the protection zone of the catheter is coated with or comprisesan embedded radio-opaque substance.
 10. The method of claim 1, whereinthe flexibility zone of the catheter is coated with or comprises anembedded radio-opaque substance.
 11. The method of claim 1, wherein thepushability zone of the catheter is coated with or comprises an embeddedradio-opaque substance.
 12. The method of claim 1, wherein the catheterfurther comprises a transition area resided between two adjacent zonesof different flexibility, wherein the transition area has a flexibilitythat is intermediate between the flexibilities of the two zones.
 13. Themethod of claim 1, wherein the catheter further comprises a strainrelief area between the pushability zone and the connector.
 14. Themethod of claim 1, wherein the stabilization zone and the protectionzone of the catheter have a flexibility index of less than 3000 mN. 15.The method of claim 1, wherein the flexibility zone of the catheter hasa flexibility index of less than 3500 mN.
 16. The method of claim 1,wherein the trackability zone has a flexibility index of less than 4500mN.
 17. The method of claim 1, wherein the pushability zone of thecatheter has a flexibility index of less than 6000 mN.
 18. The method ofclaim 1, wherein the stabilization zone and the protection zone of thecatheter have a flexibility index of less than 3000 mN, the flexibilityzone of the catheter has a flexibility index of less than 3500 mN, thetrackability zone of the catheter has a flexibility index of less than4500 mN, and the pushability zone of the catheter has a flexibilityindex of less than 6000 mN.
 19. The method of claim 1, wherein thediameters of the zones of the catheter are the same as one another. 20.The method of claim 1, wherein the diameters of the zones of thecatheter are different from one another.
 21. The method of claim 1,wherein the advancing device comprises a guiding extension connected tothe base handle and extending in a direction parallel to the deploymentextension, and wherein the first handle comprises a stabilizing ringfitting over the guiding extension and longitudinally slidable thereoversuch that movement of the first tubular member is controlled androtation of the first tubular member relative to the base member isprevented.